Ezetimibe / Simvastatin News

MONDAY, Nov. 21, 2016 – Because the irregular heartbeat known as atrial fibrillation can trigger stroke-inducing clots, many patients are prescribed a blood thinner. But a new Canadian study suggests that combining one blood thinner, Pradaxa, with certain statin medications could raise the odds for bleeding in these patients. "An increase in the risk of bleeding requiring hospital admission or emergency department visits was seen with lovastatin [Mevacor] and simvastatin [Zocor] compared with the other statins," said study author Tony Antoniou, a pharmacist at St. Michael's Hospital in Toronto. His team tracked outcomes for nearly 46,000 patients ages 65 and older. All had atrial fibrillation and took Pradaxa (dabigatran) to reduce their risk of stroke. Those who also took either lovastatin or simvastatin had a 40 percent higher risk of bleeding than those who took other statins, the ... Read more

TUESDAY, Sept. 27, 2016 – Statins are the go-to therapy for lowering "bad" LDL cholesterol, but other treatments also can effectively reduce risk of future heart problems, a new evidence review reports. These alternative therapies – including a heart-healthy diet, other cholesterol-lowering medications, and even intestinal bypass surgery – seem to confer the same level of heart health protection as statins when cholesterol levels decrease, according to the findings. Nonstatin therapies reduced the risk of heart problems by 25 percent for each 1 millimole per liter (mmol/L) decrease in LDL cholesterol levels. That's very similar to the 23 percent reduction per 1 mmol/L decrease seen with statins like atorvastatin (Lipitor) and simvastatin (Zocor), the researchers said. What's more, the benefits of these therapies stack up if more than one proves effective at lowering a person's ... Read more

MONDAY, June 20, 2016 – Giving high doses of statins to patients with heart disease doesn't lower the risk of future heart trouble any more than moderate doses of the cholesterol-lowering drugs do, a new study finds. Having heart disease raises the risk of heart attack and stroke, as blood vessels become clogged and cut the normal flow of blood and oxygen to the heart. These patients are typically prescribed statins on a long-term basis, to lower levels of vessel-clogging LDL ("bad") cholesterol. But experts remain conflicted about exactly how low LDL cholesterol levels should go. "Our study demonstrates that physicians treating patients with heart disease and elevated levels of cholesterol with statins have to ensure that patients meet a target of less than 100 mg/dL to prevent future [heart] events," said study author Dr. Morton Leibowitz. He is a senior physician with the Clalit ... Read more

TUESDAY, April 26, 2016 – Long-term use of cholesterol-lowering statins does not appear to reduce the risk of colon cancer, but a person's cholesterol levels might affect risk, a new study suggests. Both statins and cholesterol levels have been linked with lower colon cancer risk, but pinpointing which one is actually responsible has been difficult, the University of Pennsylvania researchers explained. So, they compared statin use and cholesterol levels in more than 22,000 British patients with colon cancer and more than 86,500 without the disease. The results confirmed findings from previous studies that showed a lower risk of colon cancer in people who take statins. But the risk was not significantly different between people who kept taking statins and those who stopped taking the drugs. Instead, the higher the cholesterol level, the lower the colon cancer risk for patients, ... Read more

WEDNESDAY, Dec. 2, 2015 – News reports on the downsides of statins may push some people to stop taking the cholesterol-lowering drugs, a new study hints. The findings, published Dec. 2 in the European Heart Journal, cannot prove that media stories drive statin users to give up their prescriptions. Instead, Danish researchers found a broad correlation between "negative" media coverage and people's odds of quitting a statin within six months of their first prescription. But even without a clear cause-and-effect connection, experts said it's reasonable to assume that media stories had an influence over some statin users in the study. It rings true to Dr. Thomas Whayne Jr., of the Gill Heart Institute at the University of Kentucky. "I've seen this happen a lot," said Whayne, who was not involved in the study. "News stories come out, and you have patients saying, 'I'm not going to take ... Read more

TUESDAY, May 19, 2015 – More than one-third of U.S. adults have a combination of health problems collectively known as metabolic syndrome that increase the risk of heart disease and diabetes, according to new research. What's worse, the researchers found the rate of metabolic syndrome increases dramatically with age. Almost half of people 60 or older in the United States have metabolic syndrome, the study found. "That's concerning, because we know the population of the U.S. is aging," said senior author Dr. Robert Wong, an assistant clinical professor at University of California, San Francisco. "I think it will potentially place a huge burden on our health care system." Metabolic syndrome is a "perfect storm" of conditions that include high blood pressure, abnormal cholesterol levels, increased levels of blood sugar, and a wider waist circumference, Wong said. Medical experts are ... Read more

FRIDAY, May 1, 2015 – Taking the cholesterol-lowering medications known as statins for a year before getting a diagnosis of lung cancer was associated with a 12 percent lower risk of dying from that cancer, new research suggests. The researchers from Northern Ireland also found indications that those who had a minimum of 12 statin prescriptions filled after being diagnosed with lung cancer saw their lung cancer death risk drop by as much as 19 percent. But, study lead author Chris Cardwell stressed that the degree of the association seen between statin use and a lower risk for lung cancer death was "relatively small." And while the study found an association between statin use and a lower risk of lung cancer death, it wasn't designed to prove a cause-and-effect relationship. Cardwell said there are any number of other differences between patients who take statins and patients who don't ... Read more

MONDAY, Nov. 17, 2014 – Driving "bad" LDL cholesterol down to extremely low levels with a combination drug appears to significantly reduce heart attacks and strokes in high-risk patients with clogged arteries, a new study found. Patients experienced fewer heart attacks and strokes when taking Vytorin, a drug that combines a cholesterol-lowering statin called simvastatin with a non-statin medication called ezetimibe, said principal investigator Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston and a professor at Harvard Medical School. Vytorin reduced LDL cholesterol levels in patients to just under 54 milligrams per deciliter (mg/dL) of blood. That's far below where cholesterol levels ended up with statin therapy alone – 69 mg/dL, according to the researchers. This is the first study to show that reducing bad cholesterol by combining statins with ... Read more

ISSUE: FDA has approved important safety label changes for the class of cholesterol-lowering drugs known as statins. The changes include removal of routine monitoring of liver enzymes from drug labels. Information about the potential for generally non-serious and reversible cognitive side effects and reports of increased blood sugar and glycosylated hemoglobin (HbA1c) levels has been added to the statin labels. The lovastatin label has been extensively updated with new contraindications and dose limitations when it is taken with certain medicines that can increase the risk for muscle injury. Read the FDA Drug Safety Communication for more information. BACKGROUND: Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). Marketed as single-ingredient products, including Lipitor ... Read more

TUESDAY, Feb. 28 – The popular cholesterol-lowering drugs called statins will now come with revised labels warning of a slight increased risk of elevated blood sugar levels, which could lead to type 2 diabetes, as well as a warning on rare cases of confusion and memory loss, U.S. drug regulators said Tuesday. But the U.S. Food and Drug Administration, which made the announcement, and health-care professionals all stressed that the heart-protective benefits of statins – which include drugs such as Crestor, Lipitor, Pravachol and Zocor – far outweigh the risks spelled out on the new labels. "We want health-care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol," Dr. Mary Parks, director of the FDA's Division of Metabolism and ... Read more

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 25, 2012 - Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved an updated label for Vytorin (ezetimibe/simvastatin) that includes results from the Study of Heart and Renal Protection (SHARP). In SHARP, Vytorin 10/20 mg lowered LDL cholesterol in patients with moderate to severe chronic kidney disease (CKD), and major vascular events were reduced in the treatment group compared to placebo. The trial therefore demonstrated that treatment with Vytorin 10/20 mg versus placebo reduced the risk for major vascular events in this CKD population. Because SHARP studied the combination of simvastatin and ezetimibe compared with placebo, it was not designed to assess the independent contributions of each drug to the observed effect; for this reason, the FDA ... Read more

Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor [UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction. [Posted 06/08/2011] ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher ... Read more

Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor [Posted 06/08/2011] ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney ... Read more